With the globalization of the new crown virus spreading, everyone may have a little fear or fear in their hearts. Anti-epidemic supplies have become a necessity for people around the world. Masks are one of the necessities of everyone and a consumable that is just needed every day. Therefore, many non- Companies that specialize in personal protection products have joined the list of contributors to the fight against the epidemic. With the effective control of the epidemic by the Chinese government, everyone’s daily life has gradually returned to normal; however, the epidemic abroad is not optimistic. As of 10:00 on March 22, 2020 Beijing time, it has exceeded 224,000, which is nearly three times that of China, especially the European Union. Member States are ranked the most severely in the first place. Therefore, some companies that do not focus on personal protection products want to take a share or contribute a little in this market, and CE and other related certifications have become their first obstacle to opening the country.

The reason for writing this article is that I have received a lot of calls from friends in the last two weeks to inquire about CE certification related matters; after I communicated in depth, I learned that they have invested millions of dollars in this fight against the epidemic. Don’t wait, and many companies have not sold any products. One of them is that CE and other related certification certificates have not been obtained. There are many business leaders crying about this in a hurry. I am a little sad to hear this information. Or can’t bear it; in the current self-media era, individual irresponsible official accounts even publish unconfirmed content, which makes it difficult for these companies to distinguish the authenticity of the relevant content and even adds fuel to the fire. Part of the information is for testing and certification. People who have been in the field for more than ten years are difficult to distinguish, not to mention the relevant responsible personnel of these companies who have contributed to the fight against the epidemic. For example, there are many non-testing and certification industries or unofficial official accounts that export to the EU without CE. From the title, it can be seen that such people do not understand what CE is? The testing and certification industry has always adhered to the principles of fairness, impartiality and openness, and the value lies in the transmission of trust; today I will popularize some common sense professional knowledge for everyone. If there is anything that is not rigorous or accurate, please teachers and corrections. Thanks!

First: What is CE

       CE is the abbreviation of French, and the English means European Conformity, which is the European Community. The EU has 27 member states, such as France, Germany, Italy, the Netherlands, Belgium, Luxembourg, and the United Kingdom (it is not a member of the EU, January 2020 Formally Brexit on the 31st), Denmark, Ireland, Greece, Portugal, Spain, Austria, Sweden, Finland, Poland, Hungary, Czech Republic, Lithuania, etc. In fact, CE is also the abbreviation of the phrase "European Community" in many languages of the European Community. Originally, the English phrase EUROPEAN COMMUNITY was abbreviated as EC. Later, the European Community was COMMUNATE EUROPEIA in French and COMUNITA EUROPEA in Italian. , Portuguese is COMUNIDADE EUROPEIA, etc., so the EC certification is changed to CE certification, which is one of the mandatory certifications of the European Union, and different products correspond to different regulations and standards. It is recommended that you must study relevant regulations and standard requirements.

Second: CE certification agency

1. The Declaration of conformity issued by the enterprise itself, referred to as DOC. This certificate is a self-declaration and should not be issued by a third-party agency (such as a testing and certification agency). The enterprise can use the corresponding regulatory “Declaration of Conformity” "Book", many well-known companies have issued DOC certificates, just for credibility or recognition;

2. Certificate of compliance, COC for short, is a declaration of compliance issued by a third-party testing and certification body, which must be accompanied by test reports and related technical materials, and the company must also sign the "Declaration of Compliance". This kind of certificate has been seen the most;

3. EC Attestation of conformity "Certificate of Conformity to EU Standards", this is a certificate issued by the EU Notified Body (Notified Body for short NB). According to the relevant EU product regulations, the EU NB organization corresponding to the CE certification of the product is eligible to issue EC Type CE certificate.

Third: Relevant regulations and directives (partial)

Fourth: CE marking

Not issued by any official, certification body or laboratory, but made and affixed by the manufacturer or its agent according to the relevant certification model; the mark must be made in accordance with the requirements of the European Union, and the mark must be in a prominent position on the product or its packaging. The minimum height of the entire sign shall not be less than 5mm.

Fifth: Regulations, standards and test items for protective masks

1. The grades of protective masks are divided into FFP1, FFP2 and FFP3. Protective masks are shown in Figure 1

The applicable regulations for protective masks are (EU) 2016/425. According to the risk protection level, protective masks belong to Class III products. The test standard is EN149:2001+A1:2009. To meet this standard, the mask must have a covering mouth and nose and be completely composed of filter material (or mask + non-removable filter material); it should be noted here that the flat mask in Figure 2 does not meet the standard EN149:2001+A1:2009 test Requirements (usually the leakage rate and leakage performance are not up to the requirements), only the relevant medical standards can be used for export, and the PPE directive cannot be used for export to the EU.

2. According to (EU) 2016/425 regulations, protective masks must obtain Module B (type inspection certification) + Module C2 (sampling test, valid for one year) or Module D (factory audit, valid for three years) certificate, It can be legally sold in the EU; in simple terms, it must be Module B+Module C2 or Module B+Module D. Usually there are two certificates. It is strongly recommended that relevant companies carry out CE certification in accordance with this regulation (products must comply with the standard, with a period of more than 2 months, and can bear certification related costs). You can choose a suitable certification body for testing and certification according to your own needs. I will not repeat it here. , If you need to recommend, you can leave a message or call 400 for consultation.

3. The main test items for protective masks are filtration efficiency, resistance, and leakage rate. The filtration efficiency can usually reach FFP2 (filtration efficiency 94%). The national standard GB 2626-2019 (implemented on July 1, 2020) has a filtration efficiency higher than the European standard The requirements are even higher. Companies that meet the requirements of the national standard can try to apply for the FFP3 level; it should be noted that the face shape of Europeans is different from that of Chinese people, and there is a risk of failure to pass the leakage rate; EU standards also have strict requirements on the use time of masks , Divided into reusable (the European Union has an unwritten rule of 8 hours) and non-reusable; Europeans usually wear a mask with a head, it is recommended to change the ear-mounted type to a head-mounted type (the European standard test model is also Without ears).

Sixth: CE certification technical information

1. Risk assessment report: In order to deal with the possible risks in the use of the product, the measures taken in the product design and production process (for example: how to prevent the headband from falling off or the allergies of different skins);

2. List of basic health and safety: ZA list (there are clear requirements in the regulations, to list item by item, this is relatively simple, just fill in the standard appendix);

3. Product design drawings: exploded drawing, size, location drawing;

4. Catalog of harmonized standards, all harmonized standards are mandatory standards, such as EN149:2001+A1:2009;

5. Test report: A test report issued by a laboratory authorized by CNAS is required, and the report date is within three years;

6. Product identification and packaging information (see chapters 9.1 and 9.2 of the standard EN149): such as the latest date of use, instructions, storage temperature, and humidity requirements during transportation. Or become smaller);



7. Instructions: In accordance with EN149 Standard Article 10 Information and Regulations (EU) 2016/45 Appendix II ESSENTIAL HEALTH AND SAFETY REQUIREMENTS Clause 1.4 Manufacturer's instructions and information.

8. Declaration of Conformity (DOC): Customs inspection, product information (such as name, model, picture, etc.), manufacturer information, certification body information, certificate information; usually there are two ways to provide (one or one in each package) Download from official website link, it is more convenient to use the first method);

9. List of raw materials: such as product grade, model, and supplier;

10. Quality control procedures: ISO9001, process flow chart, inspection plan and records;

11. List of purchased parts: such as nose clip, headband, breathing valve, etc.;

12. Obtained CE certification.

Seventh: Refute rumors (CE certification is not required for export to the EU)

1. The European Commission issued a recommendation on compliance assessment and market surveillance procedures under the threat of COVID-19 (Commission recommendation (EU) 2020/403) on March 13, 2020. <Recommendation> said that in order to deal with the shortage of personal protective equipment and medical equipment during the outbreak, the European Commission can accept short-term conformity assessment authorization operations, provided that the products reach a sufficient level of health and safety. The <Recommendation> reiterated the regulations and instructions for the ownership of various personal protective equipment and medical equipment. Manufacturers should apply for the implementation of the applicable conformity assessment procedures in accordance with the corresponding regulations and instructions, and prove that their products meet the basic health and safety requirements. Put personal protective equipment and medical equipment with the CE mark on the EU market.

2. Document interpretation: In order to ensure the provision of appropriate personal protective equipment and medical equipment during the COVID-19 epidemic, the European Commission invites all economic operators in the entire supply chain, as well as notifying agencies and market surveillance agencies, to deploy all they have at their disposal Measures and support aimed at ensuring that the supply of personal protective equipment and medical devices across the EU market matches the growing demand. However, such measures should not adversely affect the overall health and safety level, and all relevant stakeholders should ensure that any personal protective equipment or medical devices that are being placed on the EU market continue to provide adequate protection for the health and safety of users.

2.1. If the market surveillance agency determines that the product meets the PPE regulations or the basic safety and performance requirements of the medical device, that is, the conformity assessment procedure, even if the conformity assessment is in progress, it may be allowed to perform the necessary without the CE mark. After the procedure, enter the EU market first, and the product must continue to complete its conformity evaluation process;

2.2. The authorities of member states can also evaluate and organize the purchase of personal protective equipment and medical devices without CE marking during the epidemic, but such products can only be provided to medical workers and cannot be circulated and sold on the market.

2.3. The European Commission also emphasized in the <Recommendation> that market spot checks will focus on spot checks on personal protective equipment and medical equipment related to epidemic prevention to prevent substandard products from causing serious risks.

A screenshot of the official EU information is as follows

Remark:

1. The contents of the above regulations and standards are grateful to CCQS Zhou Zong and Teacher Ma for their support;

2. All the above content is original content, if you need to reprint, please be sure to indicate the source (Dongguan Ward Testing Co., Ltd.);

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